G45 医用和食品工业用橡胶制品 标准查询与下载

ASTM D3577-06 外科用橡胶手套的标准规范

1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.The following safety hazards caveat pertains only to the test method portion, Section , of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Rubber Surgical Gloves

ASTM D7103-06e1 医用手套评估的标准指南

The standards under the jurisdiction of Committee D11.40 and other technical committees can be used individually or as part of an integrated protocol in the assessment and selection of medical gloves. The intended use of the standards is as a means by which information can be requested, generated, and reported in a consistent, comparable manner. The suggested assessments and test methods are recommended guidelines. Test methods offer procedures for assessing medical gloves at standardized conditions to allow comparison. The information on medical glove performance must be combined with professional judgment, and a clear understanding of the application, in order for the medical glove to provide the best performance. Medical gloves intended for use during emergency medical operations may be evaluated and their performance certified to NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations. This certification program is voluntary. 1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards. 1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Assessment of Medical Gloves

ISO 10282:2002/Cor 1:2005 一次性无菌橡胶外科手套.规范.技术勘误1

This is Technical Corrigendum 1 to ISO 10282-2002 (Single-use sterile rubber surgical gloves — Specification)

Single-use sterile rubber surgical gloves - Specification; Technical Corrigendum 1

ISO 11193-1:2002/Cor 1:2005 一次性医用检查手套.第1部分:用橡胶乳和胶液制成的手套规范.技术勘误1

This is Technical Corrigendum 1 to ISO 11193-1-2002 (Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution)

Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Technical Corrigendum 1

JIS T 9107:2005 一次性无菌外科用橡胶手套.规范

この規格は，医科及び歯科で手術のときに，患者及び使用者を交差感染から守るために使用する滅菌済みの使い捨て形式の手術用ゴム手袋(以下，手袋という。)について規定する。

Single-use sterile surgical rubber gloves -- Specification

DIN EN ISO 4074 Corrigendum 1:2005 天然乳胶橡胶避孕套. 要求及测试方法（ISO 4074: 2002）; 英文版本DIN EN ISO 4074: 2002-07勘误表1

Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) Corrigendum 1 to English version of DIN EN ISO 4074:2002-07

ASTM D7161-05 在常规仓库条件下到期医用手套实时有效期测定的标准实施规程

This practice provides a study design for determining shelf life of medical gloves using product in its final packaging configuration that has been stored under typical warehouse conditions.1.1 This practice covers all surgeon's and examination gloves, made from either synthetic or natural rubber latex, marketed at the time this practice is published, for which there is no previous real time aging data available, and for which there are at least 12 months of storage as finished goods under typical warehouse conditions. This practice describes how to develop real time aging data for gloves that are part of finished goods inventory (including gloves that may no longer be manufactured) in order to verify the estimated expiration date (see Note 1). Manufacturers may use this data as a starting point for real time aging studies as described in Practice D 7160.Note 18212;Accelerated aging for three-year shelf life is described in Practice D 7160.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

ASTM D7160-05 医用手套有效期测定的标准实施规程

1.1 This practice covers all surgeon's and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and analyzing the data to determine their shelf life.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Determination of Expiration Dating for Medical Gloves

ISO 8009:2004 机械避孕剂.可重复使用的天然和硅胶避孕器具.要求和试验

This International Standard specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use. This International Standard is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges and vaginal sheaths.

Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests

ASTM D6977-04 医用氯丁橡胶检查手套的标准规范

1.1 This specification provides certain requirements for polychloroprene rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.1.2 This specification covers polychloroprene rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or non-sterile or bulk non-sterile polychloroprene rubber examination gloves.1.3 This specification is similar to that of D 3578 Standard Specification for Rubber Examination Gloves, and D 6319 Standard Specification for Nitrile Examination Gloves for Medical Applications.

Standard Specification for Polychloroprene Examination Gloves for Medical Application

ASTM D7102-04 测定无菌医疗手套的内毒素的标准指南

1.1 This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate.1.2 As bacteria may continue to grow on non-sterile gloves, reportable endotoxin levels are only appropriate for sterile gloves.1.3 This guide is not applicable to the determination of pyrogens other than bacterial endotoxins.1.4 The sample preparation method described must be used regardless of the test method selected. This method does not describe laboratory test method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed.1.5 The safe and proper use of medical gloves is beyond the scope of this guide.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

SANS 4074:2003 天然胶乳橡胶避孕套．要求和试验方法

Specifies the minimum requirements and the test methods to be used for condoms made from natural rubber latex which are supplied to consumers for contraceptive purposes and to assist in the prevention of sexually transmitted infections.

Natural latex rubber condoms - Requirements and test methods

SANS 16037:2003 临床试验用橡胶避孕套.物理性能测试

Intended as a guideline for clinical researchers working with condoms. Suggests a series of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it will be easier to relate the clinical results to the design and quality of the condoms used.

Rubber condoms for clinical trials - Measurement of physical properties

ASTM D3492-03 橡胶避孕套(男用避孕套)标准规范

1.1 This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the specifications for lubricants or other dressing materials that may be applied to condoms except as noted in 3.2.1.2 This specification is intended to assist buyers in obtaining condoms of consistent quality. The safe and proper use of condoms is excluded from the scope of this specification.1.3 The applicability of this specification is as a design guideline and a reference test specification. It is not intended to be a routine quality control specification for condom manufacturing operations.1.4 The annexes in this specification include important information, such as that on apparatus or materials, that is a mandatory part of the specification but too detailed for inclusion in the main text.1.5 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

Standard Specification for Rubber Contraceptives (Male Condoms)

BS EN 1400-1:2002 儿童护理用品.婴幼儿奶嘴.安全性要求和产品信息

This part of this European Standard specifies general safety requirements relating to the materials, construction, packaging and labelling of soothers. It includes also requirements relating to the instructions for use. This European Standard is applicable to products that resemble or function as a soother unless they are being marketed as medical devices. This European Standard does not apply to products designed for specialist medical applications, e.g., those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (see annex A). NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied. The standard is not applicable to feeding teats.1

Child use and care articles - Soothers for babies and young children - General safety requirements and product information

BS EN 1400-2:2002 儿童护理用品.婴幼儿奶嘴.机械要求和试验

This part of this European Standard specifies mechanical requirements and test methods for the performance of soothers for babies and young children. This European Standard is applicable to products that resemble or function as a soother unless they are being marketed as medical devices. This European Standard does not apply to products designed for specialist medical applications, e. g., those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (see EN 1400-1:2002, annex A). NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied. The standard is not applicable to feeding teats.1

Child use and care articles - Soothers for babies and young children - Mechanical requirements and tests

BS EN 1400-3:2002 儿童护理用品.婴幼儿奶嘴.化学要求和试验

This part of this European Standard specifies limits and test methods for the release of certain chemicals from materials used for the manufacture of soothers. This European Standard is applicable to products that resemble or function as a soother unless they are being marketed as medical devices. This European Standard does not apply to products designed for specialist medical applications, e.g. those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (see EN 1400-1:2002, annex A). NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied. The standard is not applicable to feeding teats.1

Child use and care articles - Soothers for babies and young children - Chemical requirements and tests

HG/T 2584-2002 橡胶工业手套

本标准规定了橡胶工业手套的技术要求、试验方法、验收规则及标志、包装、运输、贮存等。 本标准适用于以天然胶乳为主体材料制成的工、农、林、牧、渔业等使用的劳动保护手套。

Rubber Industry Gloves

NF S97-036:2002 天然胶乳橡胶避孕套.要求和试验方法

Natural latex rubber condoms - Requirements and test methods.

NF S97-532:2002 医疗信息学.有关输血的信息.不稳定的血液产品供给信息

Medical informatics - Messages concerning blood transfusion - Labile blood product delivery message.